MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for an analysis to be performed.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if the product is returned for evaluation or new information is obtained.

Event Description

The customer reported that the transmitter was getting incorrect readings.

Manufacturer Narrative

H10: additional narrative: (b)(6) reported on (b)(6) 2018 that their zm-530pa (sn: (b)(6)) was displaying incorrect readings.Service requested: exchange service performed: multiple attempts were made to contact customer and gather necessary information for investigation; however the customer was unresponsive.Investigation result(s): the root cause of the issue was unable to be identified due to lack of provided information from the customer regarding troubleshooting, device settings, and resolution details.Multiple attempts were made to gather the necessary information.Investigation of the zm-530pa displaying incorrect readings is unable to be performed as the unit could not be obtained and the customer is unresponsive.The device serial number history for the zm-530pa shows that there have been no further/previously reported issues nor servicing for incorrect readings.Review of the device history record (dhr) shows that the unit has no history of ncmr, capa, refurbishing, or other suspected defects (see attached).Trending analysis found 6 similarly reported issues regarding zm-530pa and incorrect/missing readings.An adverse trend is not suspected due to lack of provided information and there is no indication of design deficiency.Further information is unattainable at this time, therefore investigation by qa has been completed.

Event Description

The customer reported that the transmitter was getting incorrect readings.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 7791050
• MDR Text Key: 117430961
• Report Number: 8030229-2018-00322
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2019
• Distributor Facility Aware Date: 07/22/2019
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1